The EU regulator rejects the Alzheimer’s drug from Lilly – Politico

In a phase 3 trial involving 1,700 people, Kisunla slowed down cognitive drop to 35% in 18 months compared to a placebo group. But three deaths were considered to be linked to treatment, compared to one among those who took placebo.

“Europeans living with Alzheimer’s disease early symptomatic and their loved ones need an emergency of additional treatment options. Today’s disappointing opinion means that they must continue to wait,” Iuffa, executive vice-president and president of Lilly International.

Yuffa stressed that Kisunla had been approved on other markets, adding that the company “remains confident” in its safety and efficiency.

This drug class is a new approach to treating Alzheimer’s disease, targeting the amyloid plates that accumulate the brain. Only one other drug was approved in this class in Europe, Leqembi d’Eisai (Lecanemab). The EMA also rejected this medication last summer in its initial evaluation, but supported it in November in a restricted population after re -examining.

“We hope that thanks to the review process, we will be able to continue our discussions with the agency to bring Donanemab to millions of people through Europe suffering from this implacable fatal disease,” added Yuffa.